|Publication number||US7519421 B2|
|Application number||US 11/112,181|
|Publication date||Apr 14, 2009|
|Filing date||Apr 22, 2005|
|Priority date||Jan 16, 2001|
|Also published as||CA2606237A1, EP1871472A1, US20050187584, US20060241732, WO2006115877A1|
|Publication number||11112181, 112181, US 7519421 B2, US 7519421B2, US-B2-7519421, US7519421 B2, US7519421B2|
|Inventors||Stephen Denker, Cherik Bulkes, Arthur J. Beutler|
|Original Assignee||Kenergy, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (29), Non-Patent Citations (4), Referenced by (14), Classifications (15), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation in part of U.S. patent application Ser. No. 10/197,191 filed on Jul. 17, 2002, now U.S. Pat. No. 6,907,285, which is a continuation of Ser. No. 09/760,936 U.S. Pat. No. 6,445,953 that was filed on Jan. 16, 2001.
1. Field of the Invention
The present invention relates to implantable medical devices which deliver energy to cardiac tissue for the purpose of maintaining or producing a regular heart rate. Such devices are commonly referred to as cardiac pacing devices and defibrillators.
2. Description of the Related Art
A remedy for people with slowed or disrupted natural heart beating is to implant a cardiac pacing device. A cardiac pacing device is a small electronic apparatus that stimulates the heart to beat at regular rates. It includes a pulse generator, implanted in the patient's chest, which produces electrical pulses to stimulate heart contractions. Electrical leads extend from the pulse generator to electrodes placed adjacent to specific muscles of the heart, which when electrically stimulated produce contraction of the adjacent heart chambers.
Modern cardiac pacing devices adapt their pulse rate to adjust the heartbeats to the patient's level of activity, thereby mimicking the heart's natural beating. The pulse generator modifies that rate by tracking the activity at the sinus node of the heart or by responding to other sensors that monitor body motion and rate of breathing.
Different pacing needs are met by adjusting the programming of the pulse generator and by the location of the electrodes. It is quite common that the leads extend through blood vessels which enter the heart so that the electrodes can be placed in the muscle of the heart chamber requiring stimulation. This requires that the leads extend for some distance through the blood vessels and may necessitate that the leads pass through one or two heart valves. In other patients, patch electrodes are placed on the exterior heart surface with wires extending through tissue to the pacing device. With either type of lead placement, it is important that the electrodes be attached to the proper positions on the heart to stimulate the muscles and produce contractions. Thus it is desirable to properly locate the electrodes for maximum heart stimulation with minimal adverse impact to other physiological functions, such as blood circulation.
Other patients have hearts that occasionally go into fibrillation where the heart has very rapid shallow contractions and, in the case of ventricular fibrillation, may not pump a sufficient amount of blood to sustain life. Administration of a controlled electrical shock to the heart often is required to restore a normal rhythm. A defibrillator often is implanted in the chest cavity of a person who is susceptible to recurring episodes of ventricular fibrillation. Similar to a pacing device, the implanted defibrillator senses the rapid heart rate during fibrillation and applies a relatively high energy electrical pulse through wires connected to electrodes attached to the exterior wall of the heart or to leads in the heart chamber. The defibrillator generates a much more intense electrical pulse than is used by pacing devices which merely stimulate contractions of the heart.
A common heart condition is atrial fibrillation in which the upper chambers, the atria, of the heart quiver instead of beating effectively. Rapid atrial beating produces a corresponding rapid beating of the ventricles. Electrical cardioversion and drugs have been used to restore the heart's normal rhythm. Chronic atrial fibrillation, in which a normal rhythm could not be restored, is commonly treated with medication, such as beta blockers, to slow the rapid heart rate.
Scientific research on dogs discovered that transvenous parasympathic, or vagal nerve stimulation can be employed to slow the rapid ventricular rate induced by atrial fibrillation. In this treatment, an electrode at the tip of a catheter is fed through the blood vessels to a parasympathic nerve stimulation site in the inferior vena cava of the heart. During atrial fibrillation, electrical pulses were applied from an external source through a conductor in the catheter to the electrode, thereby stimulating the site in the inferior vena cava. Specific patterns of stimulation pulses slowed the ventricular rate.
An apparatus for stimulating a vagal nerve in an animal includes a power transmitter that emits a radio frequency signal. A stimulator, for implantation in a blood vessel adjacent the vagal nerve in the animal, has a pair of electrodes and an electrical circuit thereon. The electrical circuit receives the radio frequency signal and from the energy of that signal derives an electrical voltage. The electrical voltage is applied in the form of pulses to the pair of electrodes, thereby stimulating the vagal nerve.
In the preferred embodiment, the derived voltage is stored by a capacitor and a switch is periodically operated to apply the stored voltage across the pair of electrodes.
The vagal nerve stimulation apparatus can be combined into conventional implanted cardiac pacing or defibrillator devices.
With initial reference to
The procedure for implanting the intravascular stimulator 30 is similar to that used for conventional vascular stents. For example, the balloon at the end of a standard catheter is inserted into the intravascular stimulator 30 in a collapsed, or reduced diameter, configuration. That assembly then is inserted through an incision in a vein or artery near the skin of a patient and pushed through the vascular system to the appropriate location adjacent the heart 10. Specifically, the intravascular stimulator 30 ultimately is positioned in a cardiac blood vessel 14 adjacent to a section of the heart muscle where stimulation should be applied. The balloon of the catheter then is inflated to expand the intravascular stimulator 30, thereby slightly enlarging the blood vessel 14 which embeds the intravascular stimulator 30 in the wall of the vein or artery, as seen in
With reference to
Therefore, instead of coupling the pacing device to the electrodes by wires extending through the vascular system and even the heart itself, the present invention employs radio frequency signals to provide that coupling. This eliminates the need for electrical leads that extend through the blood vessels which can break thus disabling the cardiac pacing. Furthermore, the present intravascular stimulators 30 and 31 can be located in the cardiac blood vessels 14 at points that are directly associated with the specific muscles requiring stimulation.
With reference to
Alternatively, the plurality of intravascular stimulators 30 and 31, implanted in various veins or arteries of the heart muscle, can be tuned to different radio frequencies. In this embodiment, the radio frequency transmitter 22 also is tunable to produce output signals at several different radio frequencies, in response to an electrical control signal from the pacing signal generator 20. The pacing signal generator 20 now specifies the duration and the frequency of the RF signal 16 in order to select an intravascular stimulator to stimulate the heart muscle at a particular location. As a consequence, different portions of the heart muscle can be stimulated independently and sequentially by varying the radio frequency of the emitted RF signal 16 to correspond to the frequency to which the intravascular stimulator 30 in a given location is tuned. Furthermore, the plurality of intravascular stimulators 30 can be activated in a given sequence by producing a series of pacer signals at different radio frequencies. This enables the pacing device 12 to produce a sequential contraction of the heart chambers to increase cardiac efficiency.
Intravascular electrodes also can be employed with a cardiac defibrillator 50 as illustrated in
With reference to
The radio frequency signal from the control circuit 51 has a duration that is sufficient to charge the capacitor 85 to the level necessary to deliver the electrical defibrillation pulse. Alternatively, the control circuit 51 may periodically send a brief radio frequency signal to the electronic circuitry 54 on the intravascular stimulator 52. This signal does not cause the stimulator circuit to deliver a defibrillation pulse, but is used merely to maintain the requisite charge on the capacitor 85. This ensures that the capacitor 85 will be nearly fully charged when a defibrillation pulse is required and shortens the time between receipt of the defibrillation signal and delivery of an electrical pulse to the heart. In this latter case the RF transmitter 72 sends a specially encoded control signal when the patient requires defibrillation. The RF detector 82 responds to that encoded control signal by triggering the discharge circuit 86 to deliver the electrical defibrillation pulse.
In an alternative, the fibrillation detector 70, that determines when to stimulate the patient, can be incorporated into the electronic circuit 54 on the intravascular stimulator 52. In this case, the control circuit 51 outside the body merely transmits a radio frequency signal from which the intravascular stimulator 52 derives electrical power. That electrical power is used to energize the circuitry on the intravascular stimulator 52 and charge the capacitor for electrical stimulation.
An implanted intravascular stimulator according to the present design, can also be used to stimulate vagal nerves of the heart to slow rapid beating of the ventricles that results from atrial fibrillation. The heart has several places where a vagal nerve is close to a blood vessel, such as adjacent the inferior vena cava, the superior vena cava or the coronary sinus. As illustrated in
With reference to
Another embodiment of the intravascular stimulator 102, shown in
The first stimulation electrode 109 is connected to one terminal of the storage capacitor 116. The second stimulation electrode 110 is coupled by an electrically operated switch 118 to the other terminal of the storage capacitor 116. The switch 118 is controlled by a pulse circuit 120.
When the intravascular stimulator 102 receives the radio frequency signal 103 from the power transmitter 105, the RF signal detector 114 responds by activating the pulse circuit 120. Upon being activated the pulse circuit 42 periodically closes and opens the switch 118 to apply voltage pulses from the storage capacitor 116 across the first and second stimulation electrodes 109 and 110. That action completes a circuit thereby dumping applying stimulation voltage pulses to the vagal nerve that is adjacent those electrodes.
The power transmitter 105 may continuously transmit the RF signal 103 so that the stimulator always applies a voltage pulses to the vagal nerve to control the heart rate. Alternatively the power transmitter 105 can have circuitry similar to that of the pacing device 12 which detects abnormally rapid cardiac rates and responds by transmitting the RF signal 103 to produce vagal nerve stimulation. Furthermore, the stimulator also may have additional circuitry that performs conventional cardiac pacing in which case a remote electrode is located in another blood vessel of the heart and connected to the stimulator by an electrical conductor, such as electrode 57 and conductor 56 in
In an alternative, the vagal nerve, intravascular stimulator 102 may be implemented with circuitry that detects when atrial fibrillation produces a significantly rapid heart rate that stimulation is required. In this case, the power transmitter 105 is located outside the body and merely transmits a radio frequency signal from which the intravascular stimulator 102 derives electrical power. That electrical power is used to energize the circuitry on the intravascular stimulator 102 and charge the capacitor 116 for electrical stimulation.
The foregoing description was primarily directed to a preferred embodiments of the invention. Even though some attention was given to various alternatives within the scope of the invention, it is anticipated that one skilled in the art will likely realize additional alternatives that are now apparent from disclosure of embodiments of the invention. Accordingly, the scope of the invention should be determined from the following claims and not limited by the above disclosure.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4702254 *||Dec 30, 1985||Oct 27, 1987||Jacob Zabara||Neurocybernetic prosthesis|
|US5170802||Jan 7, 1991||Dec 15, 1992||Medtronic, Inc.||Implantable electrode for location within a blood vessel|
|US5405367 *||Mar 3, 1993||Apr 11, 1995||Alfred E. Mann Foundation For Scientific Research||Structure and method of manufacture of an implantable microstimulator|
|US5411535||Mar 2, 1993||May 2, 1995||Terumo Kabushiki Kaisha||Cardiac pacemaker using wireless transmission|
|US5531779||Jan 24, 1995||Jul 2, 1996||Cardiac Pacemakers, Inc.||Stent-type defibrillation electrode structures|
|US5713939||Sep 16, 1996||Feb 3, 1998||Sulzer Intermedics Inc.||Data communication system for control of transcutaneous energy transmission to an implantable medical device|
|US5739795||Apr 3, 1996||Apr 14, 1998||U.S. Philips Corporation||Portable receiver with antenna|
|US5741316||Dec 2, 1996||Apr 21, 1998||Light Sciences Limited Partnership||Electromagnetic coil configurations for power transmission through tissue|
|US5814089||Dec 18, 1996||Sep 29, 1998||Medtronic, Inc.||Leadless multisite implantable stimulus and diagnostic system|
|US5954761||Mar 25, 1997||Sep 21, 1999||Intermedics Inc.||Implantable endocardial lead assembly having a stent|
|US5995874||Feb 9, 1998||Nov 30, 1999||Dew Engineering And Development Limited||Transcutaneous energy transfer device|
|US6026818||Mar 2, 1998||Feb 22, 2000||Blair Port Ltd.||Tag and detection device|
|US6061596 *||Nov 20, 1996||May 9, 2000||Advanced Bionics Corporation||Method for conditioning pelvic musculature using an implanted microstimulator|
|US6067474||Jul 31, 1998||May 23, 2000||Advanced Bionics Corporation||Implantable device with improved battery recharging and powering configuration|
|US6138681||Oct 13, 1997||Oct 31, 2000||Light Sciences Limited Partnership||Alignment of external medical device relative to implanted medical device|
|US6141588||Jul 24, 1998||Oct 31, 2000||Intermedics Inc.||Cardiac simulation system having multiple stimulators for anti-arrhythmia therapy|
|US6431175||May 6, 1999||Aug 13, 2002||Remon Medical Technologies Ltd.||System and method for directing and monitoring radiation|
|US6442413||May 15, 2000||Aug 27, 2002||James H. Silver||Implantable sensor|
|US6445953||Jan 16, 2001||Sep 3, 2002||Kenergy, Inc.||Wireless cardiac pacing system with vascular electrode-stents|
|US20020005719||Jun 13, 2001||Jan 17, 2002||Super Dimension Ltd .||Intrabody navigation and imaging system for medical applications|
|US20020026228||Nov 30, 2000||Feb 28, 2002||Patrick Schauerte||Electrode for intravascular stimulation, cardioversion and/or defibrillation|
|US20020120304||Feb 28, 2001||Aug 29, 2002||Mest Robert A.||Method and system for treatment of tachycardia and fibrillation|
|US20020128546||Nov 8, 2001||Sep 12, 2002||Silver James H.||Implantable sensor|
|US20020183791||Jul 17, 2002||Dec 5, 2002||Stephen Denker||Implantable defibrillator with wireless vascular stent electrodes|
|US20050107847||Nov 17, 2004||May 19, 2005||Deutsches Zentrum Fur Luft-Und Raumfahrt E.V.||Assembly for wireless energy communication to an implanted device|
|US20050131467||Nov 2, 2003||Jun 16, 2005||Boveja Birinder R.||Method and apparatus for electrical stimulation therapy for at least one of atrial fibrillation, congestive heart failure, inappropriate sinus tachycardia, and refractory hypertension|
|US20050187584||Apr 22, 2005||Aug 25, 2005||Stephen Denker||Vagal nerve stimulation using vascular implanted devices for treatment of atrial fibrillation|
|WO2005063332A1||Dec 22, 2004||Jul 14, 2005||Cardiac Pacemakers, Inc.||Baroreflex stimulation system|
|WO2005107852A1||May 4, 2005||Nov 17, 2005||University Of Rochester||Leadless implantable intravascular electrophysiologic device for neurologic/cardiovascular sensing and stimulation|
|1||DiMarco, Selective Vagal Nerve Stimulation for Rate Control in Atrial Fibrillation, American Medical Association, 2002.|
|2||Plisiene, et al., "Selective Transvascular Stimulation of Cardiac Autonomic Nerves: A Novel Technique", Biomedicine, Vo. 2, No. 1, Jul. 2002.|
|3||Schauerte et al., Transvenous Parasympathetic Nerve Stimulation in the Inferior Vena CAva and Atrioventricular Conduction, Journal of Crdiovascular Electrocphysiology, vol. 11, No.1, Jan. 2000.|
|4||Schauerte et al., Ventricular Rate Control During Atrial Fibrillation by Cardiac Parasympathetic Nerve Stimulation: A Transvenous Approach, Jounal of the Am. College of Cariaology. vol. 34, No. 7, 1999.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8019419 *||Sep 24, 2008||Sep 13, 2011||Dorin Panescu||Methods and apparatus for leadless, battery-less, wireless stimulation of tissue|
|US8175724 *||Dec 17, 2008||May 8, 2012||Cardiac Pacemakers, Inc.||Vascular fixation device|
|US8433398||Dec 8, 2011||Apr 30, 2013||Siemens Medical Solutions Usa, Inc.||Signal analysis system for heart condition determination|
|US9005106||Jan 31, 2008||Apr 14, 2015||Enopace Biomedical Ltd||Intra-aortic electrical counterpulsation|
|US9037244||Feb 13, 2008||May 19, 2015||Virender K. Sharma||Method and apparatus for electrical stimulation of the pancreatico-biliary system|
|US9067071||Jul 11, 2012||Jun 30, 2015||Interventional Autonomics Corporation||System and method for neuromodulation|
|US9126048||Oct 28, 2013||Sep 8, 2015||Interventional Autonomics Corporation||Neuromodulation systems and methods for treating acute heart failure syndromes|
|US9277956||Aug 13, 2012||Mar 8, 2016||Siemens Medical Solutions Usa, Inc.||System for automatic medical ablation control|
|US9289612||Dec 11, 2014||Mar 22, 2016||Medtronic Inc.||Coordination of ventricular pacing in a leadless pacing system|
|US20080195171 *||Feb 13, 2008||Aug 14, 2008||Sharma Virender K||Method and Apparatus for Electrical Stimulation of the Pancreatico-Biliary System|
|US20090177209 *||Dec 17, 2008||Jul 9, 2009||Tockman Bruce A||Vascular fixation device|
|US20140275847 *||Mar 14, 2014||Sep 18, 2014||Micron Devices, LLC||Wireless implantable power receiver system and methods|
|WO2013061164A2 *||Sep 28, 2012||May 2, 2013||Adi Mashiach||System and method for nerve modulation using noncontacting electrodes|
|WO2013061164A3 *||Sep 28, 2012||Nov 21, 2013||Adi Mashiach||System and method for nerve modulation using noncontacting electrodes|
|U.S. Classification||607/5, 607/61, 607/122, 607/33, 607/14|
|International Classification||A61N1/372, A61N1/39|
|Cooperative Classification||A61N1/36114, A61N1/395, A61N1/37211, A61N1/3787, A61N1/37205|
|European Classification||A61N1/36Z3J, A61N1/378C, A61N1/372D|
|Jun 29, 2005||AS||Assignment|
Owner name: KENERGY, INC., WISCONSIN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:DENKER, STEPHEN;BULKES, CHERIK;BEUTLER, ARTHUR J.;REEL/FRAME:016731/0689;SIGNING DATES FROM 20050617 TO 20050620
|Sep 12, 2012||FPAY||Fee payment|
Year of fee payment: 4